FDA Inspection
Rocky Mountain Lions Eye BankRocky Mountain Lions Eye Bank – FDA Inspection, Sep 27, 2024
Record Details
This FDA Inspection record concerns Rocky Mountain Lions Eye Bank, with an inspection on September 27, 2024, issued by the Denver District Office, covering biologics.
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ID · 93cab28c-7fc2-47cf-ba4a-a9f60faefc24
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1250468
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
4- 21 CFR 1271.75(d)Donors with risks not determined ineligible
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.47(a)Design of procedures to ensure compliance
- 21 CFR 1271.160(b)(4)Training of personnel
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Rocky Mountain Lions Eye Bank
5| Date | Classification | Office | Project area |
|---|---|---|---|
| April 26, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 21, 2015 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| February 16, 2012 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| August 12, 2010 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| February 3, 2009 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Rocky Mountain Lions Eye Bank
- FDA Inspection 1057040 - 2018-04-26
- FDA Inspection 951842 - 2015-08-21
- FDA Inspection 769336 - 2012-02-16
- FDA Inspection 676302 - 2010-08-12
- FDA Inspection 563285 - 2009-02-03
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